Gouëffic Yann, Dubosq-Lebaz Maxime, Heautot Jean-François, Tricotel Aurore, Sauguet Antoine
Vascular & Endovascular Department, Groupe Hospitalier Paris Saint Joseph, Paris, France.
Vascular & Endovascular Department, Lille University Hospital, Lille, France.
Catheter Cardiovasc Interv. 2025 Jul;106(1):680-690. doi: 10.1002/ccd.31581. Epub 2025 May 19.
Clinical studies have demonstrated the safety and effectiveness of drug-coated balloon (DCB) angioplasty for femoropopliteal revascularization. Long-term studies in routine practice are limited.
The aim of this study was to assess long-term outcomes after DCB angioplasty for femoropopliteal peripheral artery disease in a real-word-French population.
Patients with lower-limb PAD treated with at least one IN.PACT Admiral DCB in the year 2018 were identified from the French National Health Data System, representing > 99% of the French population. Primary outcomes were all-cause mortality, major amputation (including target and nontarget limbs and vessels), and reintervention (any infrainguinal reintervention or new intervention of the target lesions, nontarget lesions, target limbs, or contralateral limbs) within 1 year from the date of angioplasty. Patients were followed for 3 years from the date of angioplasty.
A total of 3595 patients (average age 71.2 years) were enrolled, including 35.7% females, 35.3% with chronic limb-threatening ischemia (CLTI), 38.2% with diabetes, and 35.9% with a history of revascularization. All-cause mortality was 7.5% at 1 year and 19.7% at 3 years. The major amputation rate was 2.7% at 1 year and 4.6% at 3 years. The total reintervention rate was 25.9% at 1 year and 43.4% at 3 years. Three-year rates were significantly higher in patients with CLTI (vs. patients with intermittent claudication), diabetes (vs. no diabetes), and prior revascularization (vs. no prior revascularization).
This real-world analysis with long-term follow-up showed satisfactory limb salvage and low mortality following angioplasty with DCBs for the treatment of femoropopliteal artery disease.
临床研究已证明药物涂层球囊（DCB）血管成形术用于股腘动脉血运重建的安全性和有效性。常规实践中的长期研究有限。
本研究的目的是评估在法国真实人群中，DCB血管成形术治疗股腘动脉外周动脉疾病后的长期结局。
从法国国家卫生数据系统中识别出2018年接受至少一次IN.PACT Admiral DCB治疗的下肢外周动脉疾病患者，该系统覆盖了超过99%的法国人口。主要结局指标为血管成形术日期起1年内的全因死亡率、大截肢（包括目标和非目标肢体及血管）以及再次干预（任何腹股沟下再次干预或目标病变、非目标病变、目标肢体或对侧肢体的新干预）。患者从血管成形术日期起随访3年。
共纳入3595例患者（平均年龄71.2岁），其中女性占35.7%，35.3%患有慢性肢体威胁性缺血（CLTI），38.2%患有糖尿病，35.9%有血运重建史。1年时全因死亡率为7.5%，3年时为19.7%。1年时大截肢率为2.7%，3年时为4.6%。1年时总再次干预率为25.9%，3年时为43.4%。CLTI患者（与间歇性跛行患者相比）、糖尿病患者（与无糖尿病患者相比）和既往有血运重建史患者（与无既往血运重建史患者相比）的3年发生率显著更高。
这项长期随访的真实世界分析表明，DCB血管成形术治疗股腘动脉疾病后，肢体挽救效果良好且死亡率较低。
